Abstract Details

Title Intravenous Ibuprofen for Acute Migraine Treatment: A Double-Blind Randomized Placebo-Controlled Pilot Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 198

Objective

To evaluate the efficacy and safety of intravenous ibuprofen for acute treatment of migraine.

Background Patients with severe migraine in an ambulatory setting have limited treatment options, especially if they experience emesis or gastroparesis. IV nonsteroidal anti-inflammatory drugs (NSAIDs) are an important alternative to oral NSAIDs. Currently, there are 3 IV NSAIDs available for use in moderate and severe pain. Yet, no placebo-controlled trial of IV NSAID for the treatment of acute migraine exists. We performed a single-center, double-blind, randomized, placebo-controlled pilot study to evaluate IV ibuprofen as an acute treatment of migraine.

Design/Methods Patients with episodic migraine were screened at Jefferson Headache Center and treated for migraine attacks within 2 to 72 hours following headache onset. Patients received either 800mg of IV ibuprofen or 250ml saline bolus. Migraine pain intensity and associated symptoms were assessed at time points following treatment. The primary endpoint was pain relief at 2 hours post infusion and important secondary endpoints included pain freedom, sustained relief, use of rescue, and absence of associated symptoms.

Results Forty-four patients received treatment with 23 randomized to ibuprofen. 2 hours post-treatment, pain relief was found in 73.9% of patients who received IV ibuprofen and 47.6% of patients who received placebo (odds ratio [OR] 3.12, 95%CI: 0.88-11.0; p=0.078). Longitudinal repeated measures analysis within 2 hours of treatment showed significant pain relief (OR 2.47, 95%CI 1.08-5.7; p=0.033) and absence of associated symptoms: photophobia (OR 4.0, 95%CI 1.57-10.3; p=0.004), phonophobia (OR 3.12, 95%CI 1.16-8.4; p=0.025), osmophobia (OR 3.45, 95%CI 1.01-11.8; p=0.048). No serious adverse events were reported.

Conclusions Although the primary endpoint was not met, pain relief and elimination of associated symptoms within 2 hours of repeated measures analysis was observed. Our results indicate that IV ibuprofen may be a safe and effective option for acute migraine, but more extensive studies are necessary.

Authors/Disclosures
John Curran PRESENTER	Mr. Curran has nothing to disclose.
Hsiangkuo Yuan, MD, PhD (Jefferson Headache Center)	An immediate family member of Dr. Yuan has received personal compensation for serving as an employee of Merck. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Dr. Yuan has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Salvia. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerenovous. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Regional Anesthesia and Pain Medicine. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Headache and Pain Reports. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. The institution of Dr. Yuan has received research support from NIH. The institution of Dr. Yuan has received research support from American Headache Society. The institution of Dr. Yuan has received research support from Pfizer. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Grant reviewer with NIH. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Invited speaker with Chinese Stroke Association.
	No disclosure on file
Mary Hopkins	No disclosure on file
Stephen D. Silberstein, MD, FAAN	Dr. Silberstein has received publishing royalties from a publication relating to health care.

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